Quality Manager, MedSupply Americas

Company: MedAire
Location: Phoenix
Posted on: August 7, 2022

Job Description:

Quality Manager, MedSupply Americas- 23610 N. 20th Dr., Phoenix Az 85085 Overall Purpose of The JobThis role is responsible for overall compliance with all US regulatory guidelines and certifications, such as ISO 9001, ISO 13485, FDA, DEA, and State Boards of Pharmacy regulations for current MedSupply facilities in Arizona and Florida. Compliance activities will ensure quality and compliance are maintained, including appropriate storage, manufacturing of kits, distribution, wholesale, import/export (where applicable) of pharmaceuticals (including controlled substances) medical devices, and consumables.MedSupply Quality Manager is a practicing quality professional with thorough knowledge and experience in the delivery of service excellence in the healthcare, logistics, or related industry. This role will support the business in achieving outstanding levels of customer satisfaction by advising on appropriate quality tools and techniques, monitoring process performance, and identifying areas for correction and improvement. The Quality Manager will work with site management to implement actions to achieve quality and service excellence targets (KPIs) and be the liaison with customer and stakeholder representatives on all relevant quality matters. The Quality Manager will work with the corporate quality team to undertake the independent process and system audits and will provide monthly quality status updates to the management team and stakeholders. The Quality Manager will drive a culture of evaluation, learning, and improving through gathering insight, evaluating results, and implementing change. Key ResponsibilitiesQuality and Regulatory

• After appropriate training in internal processes, the Quality Manager will serve as Designated Representative / Responsible Person on State and Federal registrations, where reasonable and applicable, such as AZ Board of Pharmacy (Wholesaler and Manufacturer), FDA, DEA.
• Maintain ISO 9001 Certification and ensure continuous compliance with ISO 9001, while working toward future certification to ISO 13485.
• Ensure quality, compliance, and good documentation are maintained, including appropriate storage, manufacturing of kits, distribution, wholesale, import/export (where applicable) of pharmaceuticals (including controlled substances) medical devices and consumables.
• Ensure the quality management system at each site is developed, deployed, and continually improved meeting MedSupply Corporate Quality Management Systems, local and global standards, and ISO guidelines.
• Maintain Quality Document Library. Ensure the documentation and records are generated, maintained, and retained following Good Documentation Practices and Data Integrity Principles.
• Receive, acknowledge, report, investigate, analyse root cause, close the complaints and implement appropriate Corrective and Preventive actions (CAPAs).
• Ensure all deviations/non-conformances are identified, reported, investigated, and closed in a regulatory compliant manner.
• Impart training to the personnel on the new procedures as per the requirement. Identify the training needs for the personnel at the site.
• Responsible to lead all projects related to MedSupply America's quality and compliance initiatives.
• Conduct supplier qualifications and ensure that quality agreements are in place with applicable suppliers.
• Ensure that product recalls and returns are managed and documented as per applicable regulations and SOPs.
• Conducts periodic self-inspection to ensure the compliance and continual improvement of the quality Management Systems.
• Prepare and analyze the trends for quality aspects i.e. internal audit, non-conformances, complaints, change controls, and deviations as per the frequency of MRM. Conduct management review meetings as per the schedule.
• Liaise with the licensing and certification authorities to ensure all licenses and certifications are valid and up to date.
• Work closely with MedAire Quality Manager, MedSupply Corporate Director of Quality Assurance, and legal team to ensure quality and compliance initiatives are aligned.
• Manages the regulatory inspections, license applications (new/renewal), registration of products (pharma/devices), and response to regulatory queries, notices, and observations in a compliant manner.Required Skills and Knowledge
  • In-depth knowledge of Quality Management Systems specific to Good Storage and Distribution Practices, ISO 9001 and ISO 13485.
  • Thorough knowledge of federal, state, and GDP guidelines related to sourcing, receipt, storage, and distribution of pharmaceuticals and medical supplies.
  • Ability to work in a matrix organization with multiple stakeholders.
  • Team player that can work effectively and harmoniously with a diverse team
  • Excellent communication skills both verbal and written.
  • Be personally energetic, dynamic, positive, and enthusiastic and possess the ability to think laterally and act through reasoned decision-making.
  • Hands-on with a strong sense of urgency, and willing to "roll sleeves up."
  • Document control and change control skills.
  • Demonstrated attention to detail and ability to handle multiple tasks and apply sound judgment during demanding situations.
  • Demonstrated ability to build strong customer relationships and deliver customer-centric solutions
  • Ability to communicate verbally and in writing with clarity, brevity, and accuracy
  • Demonstrated business and technical writing skills.
  • Geographical awareness and cultural sensitivity - take a broad view when approaching issues, using a global lens
  • Proven proficiency in the following Microsoft 365 Office products: Word, Excel, Teams, Outlook, and PowerPoint. Required Work Experience
    • Minimum 5 years of experience in regulatory compliance for pharmaceutical wholesalers/distributors/manufacturers or medical device manufacturers.
    • Minimum 5 years' experience in quality management systems, such as ISO and/or GDP. ISO Auditor (9001 and/or 13485) experience is a plus.
    • Minimum 5 years' experience as Designated Representative / Responsible Person for pharmaceutical wholesaler/distributor, manufacturer, or medical device manufacturer.
    • A demonstrated commitment to high professional ethical standards and a diverse workplace. Required Qualifications
      • Bachelor's Degree or equivalent work experience
      • Certified Auditor (ISO 9001, ISO 13485) preferredRequired Languages
        • Excellent written and spoken English Travel/Rotation Requirements
          • Occasional domestic travel: infrequent international travel may be required
          • Occasional after-hours virtual meetings to accommodate global time zonesInternational SOS is an equal opportunity employer and does not discriminate against employees or job applicants based on race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.

Keywords: MedAire, Phoenix , Quality Manager, MedSupply Americas, Professions , Phoenix, Arizona